Re: FDA Final Rule

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From:"Tim Morken" <>
Date:Thu, 23 Sep 1999 07:39:22 EDT
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The manufacturer has to decide how to classify the reagent, not the user.

Tim Morken, B.A., EMT(MSA), HTL(ASCP)
Infectious Disease Pathology
Centers for Disease Control
1600 Clifton Rd.
Atlanta, GA 30333


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----Original Message Follows----
From: "Goodwin, Diana" <>
To: "'Histonet'" <>
Subject: FDA Final Rule
Date: Wed, 22 Sep 1999 09:52:53 -0400

Good Morning , Histonet.

After reading Debbie Jennings-Sienna's article in the latest edition of
NSH in Action, I am still confused as to the classification of
commercially available primary antibodies.  Are they or are they not
considered to be ASR's?  Are we or are we not, as a clinical laboratory,
required to include a disclaimer on reports to clinicians of patients on
whom our lab has performed IHC testing using commercially available
primary antibodies?

Diana Goodwin,  HT
Trenton,  NJ

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